A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients (PHACS)

This study has been terminated.
(slow enrollment and lack of continuing funds)
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Eisai Inc.
Information provided by (Responsible Party):
Charles Francis, University of Rochester
ClinicalTrials.gov Identifier:
NCT00876915
First received: March 31, 2009
Last updated: October 28, 2015
Last verified: October 2015
Results First Received: July 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Venous Thromboembolism
Pulmonary Embolism
Intervention: Drug: dalteparin injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants screened for the study but deemed low or medium risk by Khorona scoring will be offered to consent to a one time baseline blood sample. These samples will be used as the control group to establish the value of TF as a predictive marker for VTE in ambulatory cancer patients as described in the Secondary Objectives.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who undergo a baseline US/CT scan and are found to have a DVT/PE will be considered a screen failure and will not be randomized and continue on in the study. In addition, if any of the screening criteria are not met, these subjects will be considered screen failures.

Reporting Groups
  Description
High Risk Dalteparin Injection

Patients will be assigned at random to receive prophylactic dalteparin injections

dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).

High Risk No Therapy No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
Low or Medium Risk Group Subjects deemed low or medium risk for VTE by Khorona score. These subjects did not enter into the study but supplied a one-time baseline blood sample for use as a control in the studies Secondary Objective of establishing the value of TF as a predictive marker for VTE.

Participant Flow:   Overall Study
    High Risk Dalteparin Injection     High Risk No Therapy     Low or Medium Risk Group  
STARTED     50     48     101  
Week 4     38     45     0  
Week 8     33     36     0  
COMPLETED     31     34     101  
NOT COMPLETED     19     14     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
High Risk Randomized to Dalteparin Injection

Patients will be assigned at random to receive prophylactic dalteparin injections

dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).

High Risk Randomized to No Therapy No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
Low Risk Ambulatory cancer patients deemed Low risk based on a Khorona score of 0-2
Total Total of all reporting groups

Baseline Measures
    High Risk Randomized to Dalteparin Injection     High Risk Randomized to No Therapy     Low Risk     Total  
Number of Participants  
[units: participants]
  50     48     101     199  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     34     35     74     143  
>=65 years     16     13     27     56  
Age  
[units: years]
Mean (Standard Deviation)
  60  (10)     58  (12)     58  (13)     58  (12)  
Gender  
[units: participants]
       
Female     21     24     41     86  
Male     29     24     60     113  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     2     3     1     6  
Not Hispanic or Latino     48     45     96     189  
Unknown or Not Reported     0     0     4     4  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     2     2     0     4  
Asian     2     0     1     3  
Native Hawaiian or Other Pacific Islander     1     1     0     2  
Black or African American     7     8     9     24  
White     38     37     91     166  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
Canada     4     3     0     7  
United States     46     45     101     192  



  Outcome Measures
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1.  Primary:   Percentage of Patients With Venous Thromboembolisms   [ Time Frame: 12 weeks ]

2.  Primary:   Percentage of Patients Who Experienced Clinically Significant Bleeding Events.   [ Time Frame: 13 weeks ]

3.  Secondary:   The Value of Tissue Factor (TF) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients   [ Time Frame: baseline value of tissue factor ]

4.  Secondary:   The Value of D-Dimer at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients   [ Time Frame: baseline value of D-Dimer ]

5.  Secondary:   The Value of Human F12 at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients   [ Time Frame: baseline value of Human F12 ]

6.  Secondary:   The Value of Tissue Factor Pathway Inhibitor (TFPI) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients   [ Time Frame: baseline value of TFPI ]

7.  Secondary:   The Value of Factor VIIa (FVIIa) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients   [ Time Frame: baseline value of FVIIa ]

8.  Secondary:   The Value of Thrombin Antithrombin (TAT) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients   [ Time Frame: baseline value of TAT ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Charles Francis, MD
Organization: University of Rochester
phone: (585) 275-5823
e-mail: charles_francis@urmc.rochester.edu


No publications provided


Responsible Party: Charles Francis, University of Rochester
ClinicalTrials.gov Identifier: NCT00876915     History of Changes
Other Study ID Numbers: 25387
1R01HL095109-01 ( US NIH Grant/Contract Award Number )
Study First Received: March 31, 2009
Results First Received: July 24, 2015
Last Updated: October 28, 2015
Health Authority: United States: Institutional Review Board